Managing COVID-19, Accelerated Drug Approvals and Health Care Equity

With most communities eager to drop masking and call an end to the COVID-19 pandemic, public health experts say it’s more important than ever for people to use their own judgment to manage their risk.

That was just one insight from the Duke Margolis Center for Health Policy’s inaugural health policy conference, which brought together hundreds of health care and public policy leaders in Washington, D.C. April 12.

Experts from Duke and the U.S. Centers for Medicare & Medicaid Services (CMS), the U.S. Food & Drug Administration (FDA) and U.S. Department of Health & Human Services (DHHS) convened to discuss short- and long-term public health challenges COVID-19 has exposed in health equity, accessibility and affordability.

Watch the recorded conference on YouTube. Some highlights from the four-hour event:

ON A WAVE OF BA.2 COVID INFECTIONS IN THE U.S.:

Scott Gottlieb, Senior Fellow, American Enterprise Institute & Former FDA Commissioner

“We’re going through a BA.2 surge here in the mid-Atlantic… but I think we’re measuring a fraction of cases. If you look at where we were before… the ascertainment was one in four to one in three cases. We’re probably at one in seven, one in eight right now, and that may be optimistic. And so, you look at 30,000 infections that day nationally – it’s probably more like a quarter of a million, and it’s probably very concentrated here in the East Coast.

The question is whether or not this sort of BA.2 wave has a big impact. … I think it won’t have a big impact and it won’t spread nationally. … We’re probably peaking right now, even though we don’t know it. … You’ll have the summer backstop, and this will kind of burn out much like B.1.1.7 burned out last year. …  It’s just going to collapse… and then the question becomes what happens later in the year.”

ON THE PUBLIC’S POST-PANDEMIC FRAME OF MIND

Andy Slavitt, Chairman of the Board, United States of Care, former CMS administrator and pandemic adviser to the Biden administration

“In a sense, in the 1919 pandemic, it was over when the public decided it was over, and … there were a lot of deaths in that third year. But at the end of the second year the public had just said, you know, … we’re done. I think we all know that in this society, there’s a certain sense that when the majority feel[s] safe and ready to move on, that sort of decides it for everybody. But we’d be wrong to think of it as over or not – binary. There’s some adjusting we need to do to our thinking. … Right now, the public feels like, if I’m supposed to be wearing a mask, my governor, or my restaurant, or my mayor will mandate it. And if they don’t, that probably means I don’t need to wear a mask. So, there is a higher level of communication required to say to people, just because it’s not mandated – that’s actually why you should be making smarter personal decisions based upon your own circumstances. … [We need to] come to a more subtle place where people can make these individual decisions… and seriously [understand] what these individual risks and exposures are.”

ON KEEPING PREVENTION ACCESSIBLE AND FREE:

Andy Slavitt

“There are still tens of millions of people at risk because of their job, because of their family health histories, because of their personal medical situation, because of their age. … that don’t feel quite so safe, and who basically work with the public every day, and have to rely upon other people’s behavior, in a way, that puts them more at risk.

Many of us can work from home. Many of us have the have these other options. But we tend to very quickly forget about these groups, and I would say, we spent more time than we should ever, ever spend again, during the AIDS crisis, just letting people suffer. So, I think there is a there is a lens … that says we can’t just accept that as a status quo.

… There are so many structural disadvantages that people face getting vaccinated. The whole crisis sped up all of the inequities … There are innovative ways to make sure we’re caring for people responsibly and giving them more access. We can’t forget that.”

ON PROVIDING EQUITABLE CARE FOR MARGINALIZED COMMUNITIES:

Chiquita Brooks-LaSure, Administrator, CMS

“One of the key parts of health equity is not just the underserved – it is making sure we are engaging the providers and the organizations that serve the underserved. So, whether it’ a safety net, whether it’s community-based organizations, we have got to figure out how to integrate them into our programs.

We’ve seen it during COVID-19 – and many in the private sector are really thinking about this and able to do it, maybe even faster than government – saying, how did we get people vaccinated? By churches and local groups that people had relationships with. Trusted partners. We have got to engage those kinds of organizations. Here’s the tension: that’s going to require us to slow down a little bit, and to make sure we’re bringing them along and not one-size-fits-all. … We are trying to make sure we are bringing in the perspectives of stakeholders that we don’t talk to as much into our work. It will take time… we want to solve the problem fast. … but we have to do this.”

ON ACCELERATED FDA APPROVAL FOR SOME MEDICAL TREATMENTS:

Michelle McMurry-Heath, President and CEO, Biotechnology Industry Organization, former leader at Johnson & Johnson and at the FDA

“If you hearken back to 30 years ago, when HIV patients were picketing the FDA and NIH because they were facing a terminal illness with no good solutions, that is what accelerated approval is designed for. And yes, the first products that come through are not necessarily the most perfect products. If you think back to AZT, it was panacea at the time. But now we know it had a much worse side-effect profile, and was much less effective than some of the therapies that followed. That’s exactly how the science progresses, and that’s what we want to see. We can’t assume that the very first therapy across the finish line is going to be the perfect solution, and yet we can’t make the perfect the enemy of the good.”

…I think we often to fail to understand completely how FDA makes decisions. The decision for the first drug for an unmet medical need is a different benefit-risk question than when it’s the 10th therapy and when there are five other highly successful and fully disseminated products out in the market.

It is a sliding scale. And as patients, you want it to be a sliding scale, because when you’re waiting on innovation, it’s important to have access to hope. … We need plasticity in the regulatory system so that it can course-correct, because that’s critically important. And it has over time. I mean there are products from both the regular FDA approval process and the accelerated approval process that have been withdrawn from market, and they’re actually very comparable percentages.”